ClinicalTrials.gg
TerminatedNCT00523120Updated Apr 20, 2016

Topical Voltaren in Otitis Externa

A Phase 2 interventional study of diclofenac sodium and dexotc in Otitis Externa, sponsored by Sieff Medical Center. Terminated at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Sieff Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

Read the detailed description

anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

02

Conditions studied

  • Otitis Externa

Browse trials for

03

In context

Otitis Externa

22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.

This study's enrollment of 20 is below the median of 100 across 20 interventional studies indexed under Otitis Externa.

Browse Otitis Externa studies →

Lead sponsor

This is the only study on the registry with Sieff Medical Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults having otitis externa as single diagnosis mild to moderate

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Children
  • Pregnant women
  • Immune compromise
  • Starting other treatment
  • Moderate to severe otitis externa
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    1

    voltaren ophta

    Drug: diclofenac sodium

  • Active comparator
    2

    dexotic

    Drug: dexotc

Interventions

  • topical solution used in ear 5 drops 8 3/day

    Also known as: voltaren ophta

  • Drugdexotc

    aural drops

    Also known as: dexotic

06

What researchers measure

Primary outcomes

  1. reducing oral analagestic use

    Time frame: 1 week

Secondary outcomes

  1. adding an alternative treatment for otitis externa

    Time frame: 1 week

07

Study locations

1 site
  • Sieff Medical Center
    Safed, 13100, Israel
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00523120
Lead sponsor
Sieff Medical Center
Responsible party
victor kizhner (Victor Kizhner MD, Sieff Medical Center) — Principal investigator
First posted
Aug 30, 2007
Start date
Sep 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 20, 2016

Study contacts

victor kizhner, m.d.
principal investigator · Sieff Medical Center, Safed, ISRAEL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Diclofenac

Start the discussion